AZD5153 in Patients With Relapsed or Refractory Solid Tumors, Including Lymphomas

Part of paid clinical trials in Sarasota, Florida.

Sponsor
AstraZeneca
Study ID
NCT03205176
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD5153 — DRUG
    AZD5153 is to be taken as oral capsules once or twice per day each day in 21 day cycles. Dosing will continue until disease progression or other study discontinuation criteria are met.
  • Olaparib — DRUG
    Olaparib, 300 mg, will be taken BID as oral capsules.

Study Details

This is a first-time-in-man (FTIM) multicenter, dose escalation study designed to investigate the safety, pharmacokinetics, and pharmacodynamics of AZD5153 in patients with malignant solid tumors, including lymphomas.

Key Dates

Start date
Jun 30, 2017
Status verified
May 2021
Primary completion
Mar 1, 2021
Completion
Apr 8, 2021

Study Design

Enrollment
49 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: AZD5153 Monotherapy
    Patients will be enrolled in cohorts of up to 6 patients each in a dose escalating scheme to determine maximum tolerated dose (MTD). AZD5153 will be taken once per day (QD) or two times per day (BID) for 21 days as an oral capsule. Once the MTD is finalized, patients may be enrolled into an expansion cohort at the MTD.
  • Experimental: AZD5153 + Olaparib Combination Therapy
    Patients will be enrolled in cohorts of up to 6 patients each in a dose escalating scheme to determine MTD. AZD5153 will be taken as oral capsules BID in combination with 300 mg olaparib BID for 21 days.

Primary Outcome Measure

Incidence of dose-limiting toxicity (DLT). [ Time Frame: From the first dose of study treatment up to last day of cycle 1 (21 days) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Research SiteSarasotaFlorida34232-
Research SiteOklahoma CityOklahoma73104-
Research SiteNashvilleTennessee37203-

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